OncoMatch/Clinical Trials/NCT05870579
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer
Is NCT05870579 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including [68Ga]Ga-NeoB and [177Lu]Lu-NeoB for breast cancer.
Treatment: [68Ga]Ga-NeoB · [177Lu]Lu-NeoB · Ribociclib · Fulvestrant — The purpose of this trial is to estimate the recommended dose (RD) of \[177Lu\]Lu-NeoB in combination with ribociclib and fulvestrant in participants with estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor-2 (HER2) negative (HER2-) and gastrin releasing peptide receptor (GRPR) positive (GRPR+) advanced breast cancer experiencing early relapse from (neo)adjuvant endocrine therapy or who have progressed on endocrine therapy in combination with a CDK4/6 inhibitor for advanced disease.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER >10%)
estrogen-receptor positive with ER >10% (regardless of progesterone receptor (PgR) expression) breast cancer by local laboratory testing
Required: HER2 (ERBB2) negative (IHC 0, 1+, or 2+ with negative ISH)
HER2 negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (e.g. fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH), or silver in situ hybridization (SISH)) test is required
Required: GRPR overexpression (Visual Scoring Scale 2 or higher on [68Ga]Ga-NeoB PET/CT or PET/MRI)
showing [68Ga]Ga-NeoB uptake on PET/CT or PET/MRI scoring 2 or higher, based on the Visual Scoring Scale
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — (neo)adjuvant or advanced/metastatic
relapsed with documented evidence of relapse on or within 12 months from completion of (neo)adjuvant endocrine therapy (+/- CDK4/6 inhibitor) with no treatment for advanced disease OR relapsed with documented evidence of relapse more than 12 months from completion of (neo)adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression after one line of endocrine therapy (except fulvestrant) (+/- CDK4/6 inhibitor) for advanced disease OR advanced breast cancer at diagnosis that progressed with documented evidence of progression after one line of endocrine therapy (except fulvestrant) (+/- CDK4/6 inhibitor)
Cannot have received: endocrine therapy (fulvestrant)
Participant shouldn't have received prior fulvestrant treatment.
Cannot have received: CDK4/6 inhibitor (ribociclib)
Exception: dose reduction due to safety reasons
Documented evidence of prior ribociclib dose reduction due to safety reasons either in adjuvant setting or for advanced disease.
Cannot have received: radiopharmaceutical
Exception: unless 10 or more half-lives have elapsed before injection of [68Ga]Ga-NeoB or [177Lu]Lu-NeoB
Prior administration of a radiopharmaceutical unless 10 or more half-lives have elapsed before injection of [68Ga]Ga-NeoB or [177Lu]Lu-NeoB
Lab requirements
Blood counts
Adequate bone marrow and organ function as defined by the laboratory values.
Kidney function
Adequate bone marrow and organ function as defined by the laboratory values.
Liver function
Adequate bone marrow and organ function as defined by the laboratory values. Child Pugh score B or C excluded.
Cardiac function
Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed locally: QTcF interval at screening < 450 msec; Mean resting heart rate 50-90 bpm (determined from the ECG); History or current diagnosis of impaired cardiac function, clinically significant cardiac disease or ECG abnormalities indicating significant risk of safety for participants [excluded]
Adequate bone marrow and organ function as defined by the laboratory values. Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed locally: QTcF interval at screening < 450 msec; Mean resting heart rate 50-90 bpm (determined from the ECG)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA Jonsson Comp Cancer Center · Los Angeles, California
- Hoag Memorial Hospital Presbyterian · Newport Beach, California
- University of Kansas Medical Center · Westwood, Kansas
- University of Pennsylvania · Philadelphia, Pennsylvania
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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